Tumor Control, Treatment Toxicity, Quality of Life and Bio-Imaging Repository Databank (TQ-BIRD) for Cancer Patients

NCT ID: NCT05061342

Last Updated: 2026-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-27

Study Completion Date

2029-12-31

Brief Summary

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Our central hypothesis is that patient response to treatment, evaluated by full spectrum of outcome measures including tumor control, survival, toxicity, and quality of life (QoL), will correlate with biomarker expressions, which can be tested in the blood, other body fluid, imaging as well as tumor tissue (if available).

Detailed Description

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The primary biomarkers of our interest are those obtained from minimally invasive procedures and those associated with immune/inflammatory treatment responses such as lymphocyte count, immune cell subtype distribution, TGF-beta1, immunomodulating interleukins and IDO metabolites. We will measure the biomarkers pre-, during- and post-anticancer treatment for hypothesis driven studies, and bank residual biological specimen, in combination with prospectively collected data including patient/tumor/treatment factors, imaging, tumor control outcome, treatment toxicity and QOL measures. We will classify the tumor response according to RECIST criteria and qualify QoL by using the PROMIS grading system and correlate them with the corresponding biomarkers. This study will serve young investigators who are interested in biomarker studies for early diagnosis, tumor control outcome and treatment toxicity/QOL prediction, aiming to guide personalized cancer care in future.

Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cancer Patients

Those with cancer.

No experimental interventions 1. Observation; 2. Anticancer treatments, including surgery, systemic therapy, radiotherapy, Chinese traditional medicine, or palliative/supportive care.

Intervention Type OTHER

Any anticancer or palliative care

Normal (non cancer) controls

Those without cancer.

No interventions assigned to this group

Interventions

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No experimental interventions 1. Observation; 2. Anticancer treatments, including surgery, systemic therapy, radiotherapy, Chinese traditional medicine, or palliative/supportive care.

Any anticancer or palliative care

Intervention Type OTHER

Other Intervention Names

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1. Observation; 2. Anticancer treatments, including surgery, systemic therapy, radiotherapy, Chinese traditional medicine, or palliative/supportive care.

Eligibility Criteria

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Inclusion Criteria

Cancer Patients

* 18 years of age and older.
* Scheduled to receive any kind of therapy in our center.
* Performance status of ECOG 0, 1, 2, or 3.
* Able to understand QoL questionnaire.

Normal (non cancer) controls

* 18 years of age and older healthy volunteers.
* Without a history of cancer except for cured skin cancer, without any active cancer.
* ECOG Performance status 0, 1, 2, or 3.

Exclusion Criteria

Participants who have supposedly limited ability to complete the survey questionnaires of the present study will be excluded.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Queen Mary Hospital, Hong Kong

OTHER

Sponsor Role collaborator

Taizhou Hospital

OTHER

Sponsor Role collaborator

Peking University Shenzhen Hospital

OTHER

Sponsor Role collaborator

Shenzhen People's Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Henan Medical University

UNKNOWN

Sponsor Role collaborator

Fengming Kong

OTHER

Sponsor Role lead

Responsible Party

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Fengming Kong

Tenured Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Feng-Ming (Spring) KONG, Professor

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong-Shenzhen Hospital

Locations

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UHongKongShenzhen

Shenzhen, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li YANG, Dr.

Role: CONTACT

0755-86913333-2107

Facility Contacts

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Feng-Ming (Spring) KONG, Professor

Role: primary

0755-86913333-2997

References

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Zhao CN, Chiang CL, Chiu WK, Chan SK, Li CJ, Chen WW, Zheng DY, Chen WQ, Ji R, Lo CM, Jabbour SK, Chan CA, Kong FS. Treatments of transarterial chemoembolization (TACE), stereotactic body radiotherapy (SBRT) and immunotherapy reshape the systemic tumor immune environment (STIE) in patients with unresectable hepatocellular carcinoma. J Natl Cancer Cent. 2024 Nov 28;5(1):38-49. doi: 10.1016/j.jncc.2024.06.007. eCollection 2025 Feb.

Reference Type DERIVED
PMID: 40040869 (View on PubMed)

Other Identifiers

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GCOG0001

Identifier Type: -

Identifier Source: org_study_id

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